Serum Institute of India to start production of Sputnik V from September

India's top vaccine maker, Serum Institute of India (SII) will begin production of the Russian COVID-19 vaccine, Sputnik V from September 2021. This was informed by Kirill Dmitriev, CEO of the Russian Direct Investment Fund. 

Kirill Dmitriev also informed that some other manufactures are also ready to produce the vaccine in India. This will provide a major boost to India's vaccination drive. 

The Russian Direct Investment Fund informed that its deal with the Serum Institute of India envisages the annual production of more than 300 million doses of the COVID-19 vaccine in India starting in September. 

Serum Institute of India (SII) will commence production of Sputnik V in September. Some other manufactures are also ready to produce this vaccine in India: Kirill Dmitriev, CEO, Russian Direct Investment Fund pic.twitter.com/XDkh1C0Uwg

— ANI (@ANI) July 13, 2021

SII- RDIF Agreement: Key Highlights 

• The Serum Institute of India has already received the cell and vector samples from Russia's Gamaleya Centre as a part of the technology transfer process. 

• With their import approved by the Drug Controller General of India (DCGI), the cultivation process has begun in India.

• The Serum Institute of India (SII) had earlier sought regulatory approval to produce Russia's Sputnik V COVID-19 vaccine in India. 

• The Serum Institute of India is the world's largest vaccine maker and it is already making AstraZeneca PLC (AZN.L) and Novavax vaccines in India.

• The SII is currently working to ramp up the production of the Oxford-AstraZeneca vaccine, which is being sold in India under the brand name- Covishield.

RDIF Partners in India

• The Russian Direct Investment Fund (RDIF) had collaborated with many local Indian pharmaceutical players to locally manufacture Sputnik V doses including the Hyderabad-based Dr. Reddy's Laboratories, Hetero Biopharma, Gland Pharma, Stelis Biopharma and Vichrow Biotech. 

• The Russian Direct Investment Fund had partnered with Dr. Reddy’s for conducting clinical trials of the vaccine in India in September 2020, a month after it received regulatory approval in Russia. 

• On May 24th, RDIF also announced a collaboration with Panacea Biotec, one of the leading Indian pharmaceutical producers, to launch the production of the Sputnik V coronavirus vaccine in India.

• India’s Morepen Laboratories and RDIF had also signed an agreement on cooperation in June 2021 for the production of the vaccine. The laboratory has started the production of the test batch of Russia’s Sputnik V vaccine at its own facility in Himachal Pradesh and the first batch will be shipped to the Gamaleya Center for quality check. 

• The Indian government expects to have around 156 million doses of the Sputnik V vaccine between August and December 2021. 

Background

India's Subject Expert Committee had in April 2021 approved Dr. Reddy's application for emergency use authorisation to Russia's Sputnik V COVID-19 vaccine, making it the third vaccine to receive emergency use approval in India after the two locally manufactured vaccines- Bharat Biotech's Covaxin and Oxford-Astrazeneca's Covishield.

Sputnik V is a two-dose vaccine which has been found to be 91.6% effective in preventing people from getting COVID-19. The vaccine's efficacy rate is higher than the two vaccines currently approved in India.

The vaccine has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology in collaboration with the Russian Direct Investment Fund (RDIF).